FDA Medical Device Recalls (openFDA)
Biomet, Inc.: Biomet brand Absolute Bi-Polar Shoulder Shell 48 mm w/locking ring; part 113156.
- Recall number
- Z-0777-04
- Recalling firm
- Biomet, Inc.
- Product
- Biomet brand Absolute Bi-Polar Shoulder Shell 48 mm w/locking ring; part 113156.
- Status
- Terminated
- Initiated
- 2004-02-23
- Posted
- 2004-07-20
- Terminated
- 2004-04-13
- Reason
- The locking ring was not included and the shoulder implanted without the locking ring.
- Root cause
- Other
- Action
- The firm recovered the consigneed units from hospital stocks and issued a letter dated 2/23/04 to the two implanting physicians.
- Quantity
- 7
- Distribution
- California, Florida, Washington, Germany and Venezuela.
- Lot, serial or model codes
- lot 551440.
- 510(k) numbers
- ["K002998"]
- PMA numbers
- not on file
- Product code
- KWT
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28